In the News


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Healthcare provider (HCP) and payer viewpoints can be very different regarding the treatment and management of patients with chronic conditions. The HCP’s principal responsibility is to the individual, ensuring that every patient under his or her care receives the appropriate treatment necessary to optimize their patients’ health and quality of life. Although the well-being of individual patients remains the major focus, in recent years, HCPs have been forced to view healthcare delivery in a broader context, one that includes the financing side of the equation.

Multiple sclerosis (MS) is a progressive neuroimmunologic disease of the central nervous system, characterized by multiple areas of demyelination, myelin damage and scarring, loss of oligodendrocytes, and axonal and neuronal injury to the white matter of the brain and spinal cord.1 MS is a leading cause of medical neurologic disability in younger people affecting individuals in the prime of their lives, with age of diagnosis between 20 and 50 years of age.2 MS is at least two to three times more common in women than in men.2

As drug costs continue to outpace overall healthcare spending, private health insurers are seeking innovative ways to manage pharmacy utilization. In keeping with this trend, pharmacy management of specialty categories such as multiple sclerosis (MS) has begun to change in recent years.

Through a structured, interactive approach designed to facilitate collaborative discussion, the MS roundtable sought to identify areas of common ground between healthcare providers (HCPs) and payers in making clinically appropriate, value-based patient management decisions. HCPs and payers represented on the panel discussed their responsibilities, goals, and challenges in an open forum that encouraged the candid exchange of ideas.

The treatment of multiple sclerosis (MS) involves pharmacotherapy to treat disease progression, symptoms, and acute exacerbations. Patients may also engage in a number of nonpharmacologic interventions, such as physical and occupational therapy.

Prominent Cardiologist Hammers the FDA: Insufficient Funding Compromises the Science of Drug Approvals

There is a hunger for reform of the US Food and Drug Administration (FDA). To a great extent, that hunger is fueled by the prevailing sentiment in today's regulatory atmosphere—a drive to make our environment as risk free as possible when it comes to medical treatment.

Late in 2007, the U.S. Food and Drug Administration (FDA) held a public meeting chaired by Dr. Randall Lutter, Deputy Commissioner for Policy, and Dr. Douglas Throckmorton, Deputy Director for the Center for Drug Evaluation and Research, to discern the prevailing thought on the possibility of developing a behind-the-counter (BTC) status for drug access in the United States. Similar to over-the-counter (OTC) status, BTC would allow a patient to access medications at the pharmacy without seeing a doctor.

Even the most casual observer of the pharmaceutical and biotechnology industries will have noticed that in 2007, the U.S. Food and Drug Administration (FDA) issued an overwhelming number of approvable letters and a corresponding underwhelming number of approval letters for new product applications. In fact, according to a recent publication by Sagient Research, the number of approvals fell by 13% from 2006, while the number of approvable letters increased by 40%.

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